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Effect of Methylphenidate on Connectivity

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Withdrawn
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
Methylphenidate
Placebo
Sponsored by
Iris Sommer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Attention Deficit Hyperactivity Disorder, Healthy Adults, Methylphenidate, Functional connectivity, Functional Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Male sex
  • Written informed consent
  • For the Attention Deficit Hyperactivity Disorder group only: a diagnosis of Attention Deficit Hyperactivity Disorder

Exclusion Criteria:

  • Age under 18 or > 40
  • Previous or current medical, psychiatric, or neurological problems (with exception of Attention Deficit Hyperactivity Disorder group)
  • Use of psychotropic medication
  • Use of recreational drugs in the two weeks before start of the study
  • Consuming an equivalent of > 5 cups of coffee per day
  • Consuming three or more alcohol units per day
  • The presence of one or more of the contraindications or warnings against the study drug as listed in the Summary of Product Characteristic
  • Presence of any contraindication to Magnetic Resonance Imaging scanning (e.g. implanted metallic object or electronic device)

Sites / Locations

  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Attention Deficit Hyperactivity Disorder

Healthy adults

Arm Description

Adult males with Attention Deficit Hyperactivity disorder will participate in a crossover design and receive both methylphenidate and placebo on two separate days.

Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days.

Outcomes

Primary Outcome Measures

The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo.
The primary objective in the current trial is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. The main question we intend to answer in this study, is whether, and if so to what extent, methylphenidate affects the organization of brain networks.

Secondary Outcome Measures

The difference in functional connectivity as measured by functional Magnetic Resonance Imaging between participants with Attention Deficit Hyperactivity Disorder and healthy controls.
To examine if any of the effects on brain connectivity differ between participants with Attention Deficit Hyperactivity Disorder versus healthy controls.
The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate.
To examine how a reorganization of brain networks as described in the primary objective is related to improvements in cognitive performance and to blood levels of methylphenidate.
The correlation of whole brain cortical thickness and white matter volume as measured with Magnetic Resonance Imaging with both graph metrics as measured with functional Magnetic Resonance Imaging and scores on cognitive tests.
To examine if certain network structures of the brain, such as cortical thickness and white matter volume, are related to susceptibility to medication efficacy and if the structural qualities are related to cognitive performance.

Full Information

First Posted
December 21, 2012
Last Updated
February 24, 2014
Sponsor
Iris Sommer
Collaborators
Netherlands Brain Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01764672
Brief Title
Effect of Methylphenidate on Connectivity
Official Title
Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Withdrawn
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Iris Sommer
Collaborators
Netherlands Brain Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. This effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity Disorder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Attention Deficit Hyperactivity Disorder, Healthy Adults, Methylphenidate, Functional connectivity, Functional Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Deficit Hyperactivity Disorder
Arm Type
Experimental
Arm Description
Adult males with Attention Deficit Hyperactivity disorder will participate in a crossover design and receive both methylphenidate and placebo on two separate days.
Arm Title
Healthy adults
Arm Type
Experimental
Arm Description
Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days.
Intervention Type
Drug
Intervention Name(s)
Methylphenidate
Other Intervention Name(s)
Ritalin
Intervention Description
Oral dose 40mg (2 x 20mg)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Oral intake of 2 placebo tablets
Primary Outcome Measure Information:
Title
The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo.
Description
The primary objective in the current trial is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. The main question we intend to answer in this study, is whether, and if so to what extent, methylphenidate affects the organization of brain networks.
Time Frame
After the last patient has completed the last visit, which is expected to be two years after the start of the study
Secondary Outcome Measure Information:
Title
The difference in functional connectivity as measured by functional Magnetic Resonance Imaging between participants with Attention Deficit Hyperactivity Disorder and healthy controls.
Description
To examine if any of the effects on brain connectivity differ between participants with Attention Deficit Hyperactivity Disorder versus healthy controls.
Time Frame
After the last patient has completed the last visit, which is expected to be two years after the start of the study
Title
The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate.
Description
To examine how a reorganization of brain networks as described in the primary objective is related to improvements in cognitive performance and to blood levels of methylphenidate.
Time Frame
After the last patient has completed the last visit, which is expected to be two years after the start of the study
Title
The correlation of whole brain cortical thickness and white matter volume as measured with Magnetic Resonance Imaging with both graph metrics as measured with functional Magnetic Resonance Imaging and scores on cognitive tests.
Description
To examine if certain network structures of the brain, such as cortical thickness and white matter volume, are related to susceptibility to medication efficacy and if the structural qualities are related to cognitive performance.
Time Frame
After the last patient has completed the last visit, which is expected to be two years after the start of the study

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male sex Written informed consent For the Attention Deficit Hyperactivity Disorder group only: a diagnosis of Attention Deficit Hyperactivity Disorder Exclusion Criteria: Age under 18 or > 40 Previous or current medical, psychiatric, or neurological problems (with exception of Attention Deficit Hyperactivity Disorder group) Use of psychotropic medication Use of recreational drugs in the two weeks before start of the study Consuming an equivalent of > 5 cups of coffee per day Consuming three or more alcohol units per day The presence of one or more of the contraindications or warnings against the study drug as listed in the Summary of Product Characteristic Presence of any contraindication to Magnetic Resonance Imaging scanning (e.g. implanted metallic object or electronic device)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris EC Sommer, Prof, Dr.
Organizational Affiliation
UMC Utrecht
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Martijn P Van den Heuvel, Dr.
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

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Effect of Methylphenidate on Connectivity

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